MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL STEM

Catalog Number UNK HIP FEMORAL STEM

Device Problem Malposition of Device (2616)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review was not possible because the required lot code(s) was not provided.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Corrective action was not indicated.(b)(4).

Event Description

"literature article entitled, ¿primary total hip arthroplasty: a comparison of the lateral hardinge approach to an anterior mini-invasive approach¿ by nathan wayne, et al, published by orthopaedic reviews (2009), vol.1, no.E27, pp.79-84, was reviewed.The purpose of this article is to compare the outcomes of various surgical approaches used during tha surgery.The authors used competitor and depuy tha devises.Implanted depuy products: pinnacle cup, polyethylene liner, cocr 28-mm femoral head, and corail stem.The authors did not combine depuy components with competitor products.Results: the authors do not identify adverse events or patient harms with specific manufacturers.4 superficial wound infections treated with antibiotics.3 deep infections treated with revision surgery.6 cases of nerve injury to the lateral cutaneous nerve- treatment and outcome was unspecified.3 dislocations- 1 treated with closed reduction and 2 treated with head and liner exchanges.4 stem loosening treated with revision.10 intraoperative femur fractures treated with cerclage or weight bearing restrictions.4 intraoperative acetabular fractures treated with cerclage or weight bearing restrictions.2 cases of acetabular loosening treated with cup revision.1 mispositioned stem- treatment unspecified.4 major non-surgical complications: 1 intestinal perforation, 1 hypertensive crisis, and 2 cases or urosepsis.The authors do not attribute these complications to the surgical procedure or implanted devices.Therefore, these events are not reportable in this complaint.Captured in this complaint: pinnacle cup: implant loosening.Polyethylene liner: implant dislocation.Cocr femoral head: implant dislocation.Corail stem: implant loosening.Patient harms: infection, joint dislocation, nerve injury, inadequate osseointegration, fracture.

• Brand Name: UNKNOWN HIP FEMORAL STEM
• Type of Device: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 9396990
• MDR Text Key: 219781088
• Report Number: 1818910-2019-118485
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Reporter Country Code: NO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL STEM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1